Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
NCT ID: NCT03843229
Last Updated: 2019-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2019-01-27
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment group
The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
Cinobufacini injection
The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
Transarterial Chemoembolization(TACE)
TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible.
cinobufacini tablet
The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
control group
The control group only receives Transarterial Chemoembolization (TACE).
Transarterial Chemoembolization(TACE)
TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible.
Interventions
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Cinobufacini injection
The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
Transarterial Chemoembolization(TACE)
TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible.
cinobufacini tablet
The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
Eligibility Criteria
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Inclusion Criteria
* male and female.
* signed the informed consent form.
* Diagnosis:Primary liver cancer diagnosed by imaging、cell and pathology report.
* Eastern Cooperative Oncology Group (ECOG) :0-2;life expectancy more than 3 months.
* Indication for TACE,no contraindication.
* First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
* At least 8 weeks after last biotherapy.
* Surgery：had not received transplantation surgery,at least 2 weeks after last major surgery.
Exclusion Criteria
* Have the primary disease can cause the neuropathy.
* A history of other malignant tumor in recent 5 years.
* Less than 6 months after last chemotherapy or radiotherapy.
* Less than 8 months after last.
* Cinobufacini allergy.
* Had received transplantation surgery ,less than 2 weeks after last major surgery.
* Other researchers think is not suitable for this clinical trail.
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Principal Investigators
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Xiaonan Cui, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
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Central Contacts
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Jian Zhang
Role: CONTACT
Facility Contacts
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Other Identifiers
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PJ-KS-KY-2018-07(x)
Identifier Type: -
Identifier Source: org_study_id
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